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Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01394367
Enrollment
90
Registered
2011-07-14
Start date
2010-06-30
Completion date
2015-05-31
Last updated
2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

respiratory therapy, exercise therapy, oxygen uptake, quality of life, right ventricular function, severe pulmonary hypertension

Brief summary

Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.

Interventions

Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Consent form * men and women\> 18 years \<75 years * invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.

Exclusion criteria

* Pregnancy or lactation * Change in medication during the last 2 months * Patients with signs of right heart decompensation * severe walking disturbance * uncertain diagnoses * No previous invasively confirmation of PH * acute diseases, infections, fever * Serious lung disease with FEV1 \<50% or TLC \<70% of target * Further

Design outcomes

Primary

MeasureTime frameDescription
Improvement of peak O2 uptake (VO2peak) under stressup to 15 weeksThree-week inpatient rehabilitation, continuation of the training program for another 12 weeks at home (exercise group), patients in the control group continued their usual activities. After 15 weeks, training is also offered to patients in the control group.

Secondary

MeasureTime frameDescription
Changes in hemodynamics at rest and during exerciseup to 15 weeks1. Changes in hemodynamics at rest and during exercise after three weeks and 15 weeks: RAP, RVP, sPAP, DPAP, mPAP, PCWP, cardiac output, PVR, CI, SvO2 2. Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2) 3. Improved condition(NYHA class, Borg scale) 4. Changes in MRI and echocardiographic parameters of right and left ventricle: size and pump function. 5. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026